Posted by Sten Westgard, MS
A recent article about the experience of QMS tracking in a clinical laboratory in Nigeria raised some interesting questions about sources of errors in "developing world" laboratories.
Where would you expect a Nigerian Human Virology laboratory (HVL) to experience the most problems?
pre-analytical processes
analytical processes
post-analytical processes
The answer, after the jump...
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Posted by Sten Westgard, MS
While traveling in the middle east recently, I was asked by a colleague about the new US IQCP regulations, specifically how to implement them in their foreign laboratory.
Frankly, I was a bit shocked. I didn't realize that anyone outside the US was paying attention to the IQCP roll-out.
But it does raise a good question: Is IQCP a global necessity? Or merely a US idiosyncrasy?
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Posted by Sten Westgard, MS
A recent question came in from a technical support consultant for a major diagnostic manufacturer:
"It is for Free T4 analyte. Customer [has] establihed a QC range after 20 QC runs. Mean and SD were derived from 20 runs and %CV achieved from 20 runs is 1.2%. Allowable interassay precision criteria according to CLIA is 6%.
"Now when customer [applies] Mean and SD according to the established range many...times they face QC rules violations of 41s and 10x.
"So can you please suggest, when the SD is too narrow is it necessary to apply these two rules to immunoassays?"
What's your guess? I'll take a stab at an answer, after the jump.
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Posted by Sten Westgard, MS
I came across a very valuable paper in Clinica Chimica Acta on the stability of hematology controls for MCV. (Some of you are already guessing what this is going to be about...)
If you take a hematology control, how many SDs should you expect to see it shift at week 5 of use versus the first week of use? In other words, what is the SDI you should expect?
1 SDI
2 SDI
3 SDI
4 SDI
5 SDI
higher than 5 SDI
The answer, after the jump...
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